Friday, December 12, 2008

How GSK Spun Seroxat

Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today.

The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides.

The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry. The internal report carries a section which outlines how GSK planned to double sales of 'selective serotonin reuptake inhibitors (SSRI)' - the industry term for anti-depressants - by winning the marketing war against Seroxat's chief rival, Prozac, manufacured by Eli Lilly.

Written in 1998 and subsequently updated in following years, the section is entitled: 'Towards the second billion - all SSRIs are not the same' and discusses strategies to see off the threat posed by Prozac.

The document outlined how GSK intended to market Seroxat for a range of conditions other than clinical depression. Chief among these was a condition the company identified as social anxiety disorder, although other forms of anxiety were also discussed internally.

'What this document makes clear is that a number of different forms of anxiety were being targeted in a systematic way. The thrust was to move sales beyond the $1 billion to $2 billion mark by pushing it to people who were not clinically depressed,' said Professor David Healy, a psycho-pharmacologist at Cardiff University, who has given evidence to the House of Commons Health Select Committee.

Richard Brook, chief executive of Mind, the mental health charity which submitted the document to the committee, told the MPs it was 'all about developing new conditions for that drug and demolishing the arguments of other competitors about why their drug was not any good'.

In addition the document shows GSK made a great virtue of the fact that Seroxat had a relatively short 'half-life' compared with Prozac, an argument which has subsequently proven deeply controversial.

A half-life is the scientific term for how long it takes for the concentration of a drug to drop by 50 per cent in a patient's bloodstream. The company suggested Seroxat's short half-life meant patients could come on and off the drug easily, compared with those on Prozac, even to the extent that they could take 'treatment holidays'. 'There was an argument that a short half life was really good news,' Brook said.

'But five years later, Seroxat has withdrawal issues. It's the short half life that causes the problems. The substances get into the body so quickly it causes some sort of dependency reaction. So one of the things the company was saying was a benefit was actually a problem.'

In its submission to the parliamentary committee Mind said the original trial data submitted to the UK regulators by GSK showed the claim was at best 'naive and at worst seriously misleading'. It added that 'the Seroxat file is highly illustrative of using marketing information as facts'.

Concerns about the addictive properties of Seroxat saw the government ban its prescription to people under the age of 18 last year. This followed a review which found children taking it were more likely to self-harm or commit suicide.

A spokesman for GSK said Seroxat could be marketed at new conditions only after stringent testing. 'Medical authorities around the world have required that GSK study each condition separately in order to prove benefit in each condition specifically.'

Coming Soon to this blog - Some of the above files

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal